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ACCESS Model Resource

Technology & FDA Compliance

Understanding FDA requirements for digital health tools used in the ACCESS Model.

Overview

Many digital tools used in ACCESS—such as mobile applications, wearables, or remote monitoring equipment—may be subject to FDA oversight. ACCESS participants must comply with all applicable FDA requirements or otherwise operate under FDA enforcement discretion.

Key Requirement: All participating organizations must comply with applicable FDA requirements for any devices or software used in care delivery, or confirm the product is subject to FDA enforcement discretion.

What Qualifies as a Medical Device?

Under the Federal Food, Drug, and Cosmetic Act (FD&C Act), a product may be a medical device if it is intended for:

•Diagnosis of disease or other conditions
•Cure, mitigation, treatment, or prevention of disease
•Affecting the structure or function of the body

Examples in ACCESS Context

•Mobile health applications
•Wearable monitoring devices
•Remote patient monitoring equipment
•Software as a Medical Device (SaMD)
•Connected glucose monitors
•Blood pressure monitoring devices
•Mental health apps with clinical claims
•AI/ML-enabled diagnostic tools

FDA Compliance Options

1

FDA-Authorized Devices

Device has received FDA clearance (510(k)), approval (PMA), or De Novo authorization

  • •Provides reasonable assurance of safety and effectiveness
  • •Required for higher-risk devices
  • •Check FDA database to verify authorization status
  • •Review authorized indications for use
2

FDA Enforcement Discretion

FDA has stated it does not intend to enforce requirements for certain low-risk devices

  • •General wellness products focused on healthy lifestyle
  • •Certain clinical decision support tools
  • •Low-risk general wellness devices
  • •Check current FDA guidance documents for applicability
3

FDA TEMPO Pilot

FDA enforcement discretion pathway for certain digital health devices used in ACCESS

  • •Technology-Enabled Meaningful Patient Outcomes (TEMPO) for Digital Health Devices Pilot
  • •Allows manufacturers to offer devices while collecting real-world data
  • •FDA exercises enforcement discretion for devices meeting pilot criteria
  • •Supports future FDA marketing submissions with real-world evidence

About the FDA TEMPO Pilot

What Is TEMPO?

The Technology-Enabled Meaningful Patient Outcomes (TEMPO) for Digital Health Devices Pilot is an FDA initiative for manufacturers of certain digital health devices that wish to offer their devices in connection with the ACCESS Model. Under TEMPO, FDA may exercise enforcement discretion for devices that have not yet received premarket authorization, allowing their use while real-world data is collected.

Relevance to ACCESS

  • • Manufacturers can request FDA enforcement discretion for devices used in ACCESS
  • • Real-world data collected during ACCESS supports future FDA marketing submissions
  • • Enhanced beneficiary consent required when using TEMPO pilot devices
  • • Visit FDA Digital Health Center of Excellence for more info

Digital Health Tool Compliance Checklist

Regulatory Classification

Determined if product meets FDA definition of medical device
Identified applicable FDA regulatory pathway
Confirmed clearance/approval status OR enforcement discretion applicability
Reviewed authorized indications for use

Quality & Safety

Design controls in place (if applicable)
Quality management system established
Post-market surveillance procedures defined
Adverse event reporting process in place

Labeling & Claims

Intended use clearly defined
Claims supported by evidence
Labeling complies with FDA requirements
Promotional materials reviewed for compliance

Cybersecurity

Security risk assessment completed
Vulnerability management plan in place
Incident response procedures established
Data encryption implemented

Interoperability

Can integrate with CMS reporting APIs
Supports HIE data exchange
Uses standard data formats (FHIR, etc.)
Meets ACCESS technical reporting requirements

ACCESS Tools Directory

CMS will maintain an ACCESS Tools Directory to:

  • • List technology-supported care tools used by participants
  • • Promote transparency about care delivery methods
  • • Help patients and providers understand available options
  • • Support informed decision-making about ACCESS organizations

Key Resources

ResourceDescription
FDA Digital Health CenterGuidance on digital health regulation
FDA TEMPO PilotCoordinated FDA-CMS review information
CMS ACCESS Model PageOfficial model documentation
ACCESS Technical FAQDetailed compliance Q&A